Certain medications offer hope to consumers that their medical conditions will be treated in a safe and effective manner. Depakote was one of those medications. Depakote once was regarded as a break through medication for the treatment of epilepsy and manic episodes for patients with bipolar disorder. Consumers also looked to Depakote as a solution to their migraine headaches or neuropathy conditions. Depakote offered hope to patients who suffered from these medical impairments.
However, many consumers, particularly persons who were pregnant when taking the drug Depakote, did so without the knowledge that this medication poses serious medical risks. Depakote may have devastating effects for mothers who used the drug during pregnancy. Severe and permanent birth defects may arise in newborns and children whose mothers used Depakote. Studies have indicated that the side effects are the most severe if a woman took the medication during the first month of pregnancy. However, mothers who used Depakote for other time periods during pregnancy also may face the risk of similarly dangerous side effects. The risks posed by Depakote are so serious that the U.S. Food and Drug Administration (FDA) has required the manufacturers of Depakote, Abbott Laboratories, to update the drug’s safety label several times. Such safety label revisions were required in order to accurately reflect the dangerous risks that Depakote poses.
Depakote (divalproex sodium and/or valproic acid) was approved for the treatment of epilepsy in 1983 and was approved for the treatment of manic episodes in patients suffering from bipolar disorder in 1995. In 2006 the FDA required a black box warning (the strongest warning the agency can give) for Depakote. The black box warning cautioned that the serious risks which Depakote poses to unborn fetuses may outweigh the benefits of the drug. Additionally, the black box warning cautioned consumers that Depakote may also pose an increased risk of liver failure and pancreatitis to patients who use the drug.
For women who took the drug Depakote during their first trimester of pregnancy, the medication has been identified as posing the risk of severe birth defects in developing children. More common birth defects associated with the use of Depakote include spina bifida, cleft palate limb malformation, and genital malformation. However several studies have indicated that Depakote side effects may include any of the following serious medical impairments:
- Cleft palate
- Hand deformations
- Undescended testes
- Hypospadia (opening of the urethra in the wrong place)
- Heart malformations
- Limb reduction and/or deformities
- Dysplastic (abnormally developed) ribs
- Fetal death
- Neural tube malformations
- Spina bifida
- Genital malformations
Spina bifida occurs when the embryonic neural tube is not completely formed. This neural tube malformation results in the child having an opening in the vertebrae, leaving their spinal cord exposed. Many of the side effects associated with Depakote are considered life threatening and irreversible. A child could potentially suffer from a non-fatal birth defect for the rest of their lives. Not only does Depakote pose a serious risk to children who have been exposed to it, but also Depakote poses the risk of pancreatitis and liver failure to those who have taken it.
If you are a woman who took Depakote during pregnancy or a young adult who has suffered from birth defects you should be entitled to remedial action. The permanent consequences of the drug manufacturer’s failure to warn of serious Depakote side effects should not be placed on you alone. It is important that the drug manufacturer’s inadequate labeling process be remedied, and that the large drug manufacturer is held responsible for its incomplete disclosure of the dangerous side effects posed by Depakote.
If you need further information on Depakote call the Hurtline at 1-800-992-6878 or fill out an online contact form for a free legal consultation.